Quality Engineer jobs at Johnson & Johnson

GxP Quality Auditor / Senior Quality Lead Employment Type: Full-Time, On-Site Salary Range: $87,780 - $145,307/year A leading life sciences organization is seeking a GxP Quality Auditor / Senior Quality Lead to support compliance and quality governance across multiple manufacturing lines. This company partners with global pharmaceutical and biotech firms to deliver solutions that ensure regulatory excellence and operational integrity. Position Summary The GxP Quality Auditor / Senior Quality Lead will play a critical role in maintaining compliance with global regulatory standards and driving quality initiatives. This position requires expertise in pharmaceutical compliance, bracketing strategies, and regulatory interpretation in a GMP-regulated environment. Key Responsibilities Coordinate between site and global teams to align SOPs and bracketing strategy Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA requirements Develop and defend bracketing justification for multiple manufacturing lines and isolators Facilitate governance meetings, escalate risks, and report status to leadership Review and approve protocol templates, summaries, and reports for finalization Qualifications Bachelor's degree in a scientific or industry-related field Minimum 7+ years of experience in pharmaceutical manufacturing or compliance Proven experience developing bracketing and matrixing strategies Strong knowledge of FDA, EMA, and HMRA regulations Familiarity with cGMP and facility/equipment validation requirements Excellent technical writing and communication skills Ability to work full-time on-site in Greenville, NC Why Join This Team? Competitive compensation and performance-based incentives Comprehensive benefits package including medical, dental, vision, and retirement plans Paid time off, holidays, and professional development opportunities Collaborative culture with strong career growth potential

Breaking Data is a boutique healthcare marketing agency serving leading pharmaceutical, biotech, and medical device companies. We specialize in scientific storytelling, creative strategy, and high-impact communications that bring complex brand narratives to life across print, digital, and training platforms. Founded by marketers, for marketers, we pride ourselves on delivering thoughtful, intuitive, and beautifully executed work. Our team is full of “A-teamers”: curious, collaborative, detail-driven people who care deeply about the craft and the quality of what we create. We believe co-location fuels creativity, alignment, and culture. While we offer flexibility, this role is intended for someone who can work 3 days onsite in our Cherry Hill, NJ office and 2 days remote. Senior Editorial and Quality Lead (Healthcare Agency)| Boutique Life Sciences Agency Location: US-Cherry Hill, NJ Employment Type: Full-time Benefits: Health Insurance Compensation, 401K program, Paid time off, and company holidays Opportunity Overview Breaking Data seeks a meticulous Senior Editorial and Quality Lead to serve as the central hub for editorial excellence across pharmaceutical and healthcare deliverables. This hands-on role owns quality control from post-writing drafts through design, reviews, and client approvals-focusing on grammar, style mastery, layout accuracy, and workflow efficiency. Ideal for an experienced editor passionate about the craft of editing. About the Role The Senior Editorial and Quality Lead will own editorial quality control as the central hub across all deliverables-from post-medical writing drafts through design layouts, internal strategy reviews, and client approvals. This hands-on role encompasses proofreading, light editing, layout verification, and workflow coordination for slides, print materials, digital assets, training modules, and long-form content, serving pharmaceutical and healthcare clients. Work closely with medical writers, designers, strategists, and account teams to ensure grammar, style, accuracy, and layout integrity meet the highest agency and client standards. Key Responsibilities Editorial Quality Control Proofread and edit copy developed by medical writers for grammar, clarity, consistency, spelling, accuracy, AMA Manual of Style, and client-specific guidelines. Verify references, superscripts, citations, medical terminology, numeric values, units, symbols, and data formatting. Perform light editing or rewrites to address minor issues and maintain project efficiency. Brand & Compliance Consistency Ensure content aligns with each client's editorial style, tone, branding expectations, and regulatory requirements (including PI/ISI placement when applicable). Confirm correct application of references, anchors, superscripts, and citation formatting. Design & Layout Review Review designed documents and slides (PowerPoint, InDesign, PDFs) to confirm clean, consistent formatting and layout. Verify alignment between copy and design elements (tables, charts, visuals, callouts); identify inconsistencies in spacing, bullets, alignment, superscripts, or content order that could alter meaning. Process & Workflow Execution Manage editorial checkpoints and coordinate handoffs across medical writers, designers, internal strategy reviewers, and clients on multiple concurrent projects. Implement QC edits directly; track and ensure all internal, client, and MLR feedback is accurately incorporated with proper version control and file naming. Serve as the final quality assurance step before client delivery. Requirements Minimum 4-5 years of editorial or proofreading experience in a healthcare, pharmaceutical, or medical communications agency setting. Strong knowledge of the AMA Manual of Style and the ability to apply client-specific style guides and branding requirements. Experience reviewing healthcare or scientific content with a high level of accuracy for terminology, data, units, and references. Demonstrated ability to manage multiple projects and deadlines in a fast-paced, detail-oriented environment. Proficiency in Microsoft Office, Adobe Acrobat Pro, and cloud-based document systems (eg, SharePoint/OneDrive). Exceptional attention to detail and a commitment to editorial precision and quality control. Strong communication and collaboration skills for working with medical writers, designers, strategists, and account teams. Education Bachelor's degree in English, Communications, Journalism, or a related field; a life sciences background is a plus but not required for this role. Work environment Our Cherry Hill, NJ office offers a flexible and collaborative environment. We align projects with each team member's core skills, striking a balance between fun and efficiency to achieve our goals and those of our clients. This is a hybrid position, with 3 days onsite and 2 days remote. Application Process To apply, please submit your resume (and, if available, editing samples) directly through this LinkedIn job posting. Candidates selected for the next steps will be asked to complete a brief editing exercise.

Title: Manager, Quality Assurance The Quality Assurance Manager is responsible for oversight of conditions and activities in API manufacturing areas to ensure continual compliance with cGMP standards. This position requires expertise in all aspects of API manufacturing, hands-on capability, strong leadership skills, and the ability to collaborate in a cross-functional environment. The individual will work closely with all departments in the manufacturing setting and report key quality metrics to site management on a regular basis. Responsibilities: Assist the Site Quality Head with developing, implementing, and maintaining a robust quality assurance program Develop and/or review standards, policies, and procedures for all functions and departments involved in production and testing of materials Oversee and assist with site training and auditing programs, changes, investigations, validations, approval of specifications and methods, review of data and manufacturing records, and vendor qualifications Ensure immediate corrective action when non-compliance or undesired behavior by personnel is observed Make recommendations regarding facilities, equipment, personnel, procedures, and systems to strengthen the quality function Ensure data integrity principles are understood and consistently implemented across the site Lead process improvement initiatives, collaborating with Operations, Quality, and Training leadership to enhance quality processes, provide coaching, and implement updated procedures Coordinate corrective action training based on feedback from observations and evaluations Assist Site Quality Head during regulatory inspections, including implementing inspection-readiness programs and ensuring timely completion of CAPAs Partner with site stakeholders to maintain operational excellence, site-wide quality compliance, and a strong quality culture while supporting business objectives Lead and support site-wide cGMP training activities Communicate effectively with internal and external stakeholders to ensure alignment with organizational goals Ensure daily inspections are carried out Qualifications: Bachelor's Degree in Microbiology, Chemistry, or related field Minimum 5 years of GMP experience in an FDA-regulated pharmaceutical environment, including 2 years of supervisory experience OR Master's Degree in Microbiology, Chemistry, or related field with minimum 3 years of GMP experience in an FDA-regulated pharmaceutical environment, including 2 years of supervisory experience Other Requirements: Must pass a background check Must pass a drug screen May be required to pass Occupational Health Screening Preferred: Advanced degree in a related field Prior experience in a Contract Manufacturing Organization (CMO)

Title: Senior Research Metallurgist The Senior Research Metallurgist provides technical expertise in areas of materials and processes in support of all areas of the company. Initiates and conducts new material, process, and product development; works directly with customers and potential customers to resolve technical problems; and assumes leadership of R&D during the absence of the R&D Manager. Supervisory Responsibilities: Yes Duties/Responsibilities: Initiate and conduct new product development, especially in the areas of new alloy formulation, materials processing and innovative use of all Deringer-Ney processes and materials. Assist with day-to-day manufacturing problems related to materials and processing. Take lead role in the development of innovative solutions to manufacturing problems. Provide technical support to the Sales and Marketing departments. Work directly with customers and prospects to select appropriate DNI products. Perform detailed failure analyses for company, customers, and prospects. Prepare well written, professional reports for both internal and external use. Provide technical training, and support of, field sales personnel. Maintain working knowledge of technological developments in both new and existing markets and keep upper management aware of potential impact of these changes. Support new product development activities of others within the company. Initiate continuous improvement and operational excellence programs within R&D and support similar programs within the organization. ADDITIONAL RESPONSIBILITIES: Supervise activities of R&D technician(s). Undertake special projects as requested by the R&D Manager. Develop and document new test methods to support improved product quality/ reliability. Required Skills/Abilities: Extensive technical understanding of company products and processes. Well-developed interpersonal skills. Excellent writing ability. Able to prepare and make effective presentations to company employees and customers. Experience & Education Requirements: Minimum - BS degree in Metallurgical Engineering, Materials Engineering, or Materials Science and Engineering. Extensive, demonstrated understanding of alloy development and material processing. Demonstrated record of preparing high quality technical reports, whitepapers, manuscripts, or patents. Required Experience: BS + 12 years industrial research experience. MS + 5 years industrial research experience; or PhD + 1 year industrial experience Outstanding candidates at lower experience levels may be considered for a Research Metallurgist position Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift 15 pounds at times. Must be able to access and navigate each department at the organization's facilities.

Title: Manufacturing Technology Project Engineer The Manufacturing Technology Project Engineer is responsible for improving manufacturing processes by evaluating and implementing advanced engineering technologies, equipment and tooling. Oversee the procurement and implementation of manufacturing technologies within Deringer-Ney, Inc. to improve quality, efficiency and cost. Supervisory Responsibilities: None. Duties/Responsibilities: Identify and evaluate potential equipment and tooling suppliers, manage the sourcing process to secure high-quality equipment and tools at optimal cost and delivery terms. Prepare return of investment analysis to justify investment in selected technology, equipment and tooling. Work closely with internal teams (design, process and quality engineers, maintenance, etc.) to facilitate and manage overall project implementation through IQ/OQ/PQ process Foster strong relationships with vendors and oversee the design, development and fabrication of manufacturing equipment and tooling. Ensure manufacturing solutions meet the required quality standards, certifications, regulatory requirements, customer specifications, production timelines and budget. Support the Design Engineers by suggesting ideas to make the detail components or assemblies more cost effective and producible Required Skills/Abilities: Strong understanding of manufacturing processes (e.g. wire draw, strip rolling, stamping , machining, plastic injection molding). Knowledge of quality control standards and regulatory compliance, especially in medical and automotive sectors. Excellent communication, problem-solving, and project management skills. Ability to work collaboratively in a cross-functional team environment. Education and Experience: Bachelor's degree in materials science (metallurgy), mechanical engineering or Industrial Engineering. Minimum 5 years of manufacturing experience in production environment. Experience as a Metallurgy Manufacturing Engineer is strongly preferred. Physical Requirements: Prolonged periods of sitting or standing. Must be able to lift 15 pounds at times. Must be able to access and navigate each department at the organization's facilities.

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Senior Cost Engineer to join our talented team at our office located in Somerset, New Jersey. In this role, you will be assigned to projects to review, coordinate, and summarize the activities of cost control, planning and scheduling, document control, and estimating. You will also support the Project Manager in the delivery of individual projects, focusing on quality objectives and ensuring the achievement of safety objectives on assigned projects. Additionally, you will coordinate resources to achieve project goals, interact with clients on assigned projects, and promote positive relationships. Position Responsibilities Identifies and analyzes potential project problems. Develops working knowledge of prime contract requirements and applies knowledge to project activities. Coordinates review and approval from the Project Executive and/or Director of Operations, and communicates this information to the project team. Supports the Project Manager in the following: Development and maintenance of written project scopes of work and communication of this information to the project team. Development and maintenance of project schedules, including targeted and actual activity lists, durations, and sequencing logic, and communicating this information to the project team. Monitoring and reporting project costs. Development of change control documentation and related financial documentation. Coordination of safety resources to monitor site safety and correct nonconformances. Procurement and coordination of all required project resources, including intra-divisional, inter-divisional, and extra-corporate. Preparation of subcontracts, purchase orders, change control documentation, and related financial documentation. Evaluation of vendor and subcontractor invoices. Facilitating communication between project participants and producing documentation of communication between project participants. Develops a thorough understanding of contractually required quality in design and construction and supports quality assurance for the project. Supports the Financial group in the preparation of invoices to clients. Works with Document Control to ensure that all project documents are distributed, reviewed, and stored to meet project and corporate requirements. The salary offered for this role is between $100,000 and $140,000, but the actual salary offered is dependent on skills, experience, and education Qualifications & Requirements 16+ years of professional experience. Bachelor's degree in a technical field: engineering, project management, construction management. Experience in cost engineering, estimating, scheduling, and earned value management. Has a working knowledge of the project budget and identifies exceptions to the project budget throughout the execution of the project. Experience in developing and managing multiple concurrent projects and in developing and executing PMO best practices. Experience in all facets of Engineering, Procurement, and Construction Management (EPC). Professional credentialing is strongly encouraged: CCT or CCP, CST or CSP, EVP, CMIT or CCM, PMP, EIT. High level of computer expertise in multiple industry-wide software products MS Office Products Scheduling software such as Primavera and MS Project Client ERP systems such as JDE, QUAD, SAP, ARIBA, CONCUR PPM Software: Prolog, Proliance, Prism G2, Procore, Cleopatra, Cora Systems Context, Environment, & Safety A safety-minded individual who must comply with the IPS Mission Zero Safety policy. Capable of working alone or as part of a team without a significant level of supervision. The employee is frequently required to stand, walk, and sit for long periods of time with extended computer use. Experience working in both a Home Office and a Field environment. Travel to client sites as needed. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!

Employment Type: Full-Time, On-Site Salary Range: $70,000-$109,000/year A leading life sciences organization is seeking a CQV Engineer / Validation Engineer to support commissioning, qualification, and validation activities for manufacturing equipment, systems, and processes in a GMP-regulated environment. This role requires strong experience authoring and executing protocols in ValGenesis and familiarity with electronic protocol management systems. Key Responsibilities Author, edit, and execute commissioning, qualification, and validation documentation (URS, IQ, OQ, PQ) using ValGenesis Manage deviation investigations and root cause analysis; support CAPA resolution Support change management activities, including impact assessments and regression analysis Execute test scripts and document results; maintain clear, detailed records Collaborate with cross-functional teams to meet project timelines Ensure compliance with GxP and 21 CFR Part 11 requirements Qualifications Bachelor's degree in STEM (Engineering, Life Sciences preferred) 3+ years of industry experience in CQV or validation Strong experience authoring and executing protocols in ValGenesis (required) Experience setting up or implementing ValGenesis instances (preferred) Familiarity with validation lifecycle documentation and electronic protocol systems Strong problem-solving and technical writing skills Ability to work full-time onsite in Devens, MA Salary & Benefits Competitive pay plus performance-based incentives Comprehensive benefits: medical, dental, vision, life insurance, disability coverage 401(k) with employer match Paid time off, holidays, and sick time Tuition reimbursement and professional development opportunities

Manufacturing Test Engineering Manager (or Senior/Lead Test Engineer) Red Oak Technologies is partnering with our client, a leader in LiDAR sensor technology, to identify a highly skilled Manufacturing Test Engineering Manager. We are open to considering strong Senior or Lead-level Test Engineers who are ready to take on team leadership responsibilities while continuing to code daily. This role is fully onsite in San Francisco, CA. Position Overview The Manufacturing Test Engineering Manager will be a hands-on technical leader responsible for developing and maintaining production test software for high-volume LiDAR sensor manufacturing. The ideal candidate will have strong Python development skills, proven experience in test engineering for electro-mechanical assemblies, and the ability to mentor and guide a team while contributing individually on a daily basis. The role requires close collaboration with cross-functional teams to improve test coverage, reduce test time, and ensure production readiness as new products move from development into manufacturing. Key Responsibilities Develop, maintain, and improve production test software using Python for LiDAR sensor and sub-assembly manufacturing. Serve as a working manager, providing technical leadership while contributing hands-on daily. Mentor and train Test Engineers on both technical and soft skills. Establish team priorities, KPIs, and work goals aligned with product development schedules and company objectives. Collaborate with cross-functional teams on software development, verification, and validation for new product introductions. Drive continuous improvement initiatives, including test time reduction, data quality enhancements, and production process optimization. Apply software engineering best practices, including coding standards, code reviews, source control management, CI/CD pipelines, and test automation. Communicate project updates, risks, and recommendations to management and stakeholders. Ensure timely completion of team deliverables and proactively address constraints or delays. Support contract manufacturing facilities with occasional travel (less than 10%). Work full-time onsite in San Francisco, CA. Qualifications and Skills Strong proficiency in Python development (minimum 5 years). Experience with CI/CD infrastructure, GitLab, Jenkins, and SQL database design. Strong skills in debugging, programming, data collection, and data analysis. Experience using project tracking tools such as Jira, Confluence, or equivalents. Proven ability to deliver results in a fast-paced engineering environment. Excellent organizational skills with the ability to manage multiple concurrent projects. Demonstrated people management or technical leadership experience (3+ years preferred). Experience working with high-precision electro-mechanical assemblies. Preferred: Experience developing test software for high-volume production and test equipment. Education BS in Computer Science, Mechatronics, Mechanical Engineering, or a related technical field required. MS degree preferred. Additional Information Background screening is conducted by the client. The Manufacturing group has zero tolerance for misdemeanor or felony theft or robbery offenses. This position is within an electrical component manufacturing environment (not medical devices). About Red Oak Technologies Since 1995, Red Oak Technologies has been a trusted partner in the technology industry, specializing in identifying and placing highly skilled contract, permanent, and project-based professionals. We value diversity and welcome applicants from all backgrounds and experiences. Red Oak Core Values: Relationships First | Exceptional Quality and Service | Unwavering Integrity and Trust | Be Easy To Do Business With | Respect Everyone

Contract Validation Engineer - Indianapolis, IN (2 year contract) We are seeking Validation Engineers to join a leading global organization committed to advancing healthcare solutions. Key Responsibilities Execute validation activities with a strong focus on drug-handling processes to maintain audit readiness. Validate critical process parameters for aseptic handling, packaging integrity, and contamination control. Oversee qualification of equipment and systems supporting drug-handling processes, including cleanrooms and controlled environments. Develop and maintain validation documentation aligned with GMP, FDA, and EU standards, ensuring data integrity and regulatory compliance. What We're Looking For Experience in pharmaceutical validation, particularly in aseptic and drug-handling environments. Strong understanding of regulatory requirements and quality standards. Detail-oriented with excellent documentation and problem-solving skills.

SummaryRepresent quality on design teams and assure that new and sustaining product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. Be an active team member and cross-function collaborator on new product development and product sustaining project teams for implantable medical devices. Be an active team member for investigating quality complaints, examining non-conformances and executing CAPAs.Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Responsibilities: (Primary Duties, Roles, and/or Authorities) Product Development: Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors. Develop Test Protocols and Final Reports to support Regulatory 510K, PMA, CE mark and International registrations. Support Pre-Concept Front End Product Innovation Process activities for new technologies. Lead Quality Engineering Projects to improve Quality systems and Procedures. Develop design risk assessments, coordinating input from the other Design Sub-team members, and manage overall risk files for devices. Develop Final Design Verification Protocols and the subsequent Final Design Verification Reports including an analysis of all data and a decision on design acceptability. Develop Design Validation Protocols and the subsequent Design Validation Reports including an analysis of all data and a decision on design acceptability. Provide input into the project for all phases of design control documents as defined per Davol's product development process. Determine the degree of Biocompatibility testing with assistance from biocompatibility SMEs required as per ISO10993 and company procedures. Co-ordinate the testing and document results. Develop or assist in development of inspection and test methods per product specifications. Develop test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating. Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices. Develop shelf life and stability test protocols and reports as required. Process Development: Develop and document the Control System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product. Support the development of manufacturing control plans for internal and outsourced processes. Support (or lead) development of process risk assessments. Perform and/or support Process Development Studies to determine the acceptability of new processes or equipment. Design and qualify inspection test methods and equipment. Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP's, and ISO13485:2003 requirements. Lead supplier part qualification activities including mold qualification and DOEs. Support Process Transfers to the Production facilities. Other: Organize and generate detailed quality information reports to show trends and the impact of process improvements. Support Process Transfers to the production facilities. Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality Engineering. Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances. Perform DOEs and other statistical analyses to support product and process optimization or determine causes of process variation. Initiate corrective actions as required. Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted. Support goals of the Quality Assurance Department. Special projects as assigned. Education and Experience: Bachelor Degree in Engineering or Technical Sciences. 2 years minimum experience with Bachelor Degree or 1 years minimum experience with Masters Degree in Quality Engineering or related discipline including design controls, product/process validation, risk management, and technical problem solving. Knowledge and Skills: A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability. Strong Design Control understanding from concept to launch; especially in post-market activities (including complaints, failure investigations, and CAPAs). Applied Knowledge of the requirements of FDA QSR, ISO13485, ISO14971, and ISO 9001. Prior experience with combination products and absorbable technologies a plus. Proven track record of developing new products that meet customer expectations. Prior experience as a quality engineer lead on new product development teams. Prior experience interacting with Surgeons preferred. Knowledge of statistics and experience with statistical software (e.g. MiniTab), preferred. Good oral and written communication skills. Approximately 15 - 20% travel may be required. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. #earlycareer Required Skills Optional Skills . Primary Work LocationUSA RI - WarwickAdditional LocationsWork Shift

Title: STAGE QUALITE PRODUIT Company: Ipsen Pharma (SAS) Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at ********************** and follow our latest news on LinkedIn and Instagram. Job Description: > Project management : * BPM (Business Process Management) : Follow-up, coordination and management of actions linked to * Complaint * Proactive Risk Management * Supplier Management * support QC CoP for valuable projects defined > Inspection management : * Develop our Inspection Readiness program : Establish a concrete training material on good behaviors (for example) and support us for the SME prep + follow up with all sites related to the observations on 1 site applicable to all? + * Develop a storyboard for Inspection related to QSEB > Additional skills : * Energetic, curious * English * Technology and basic IT tools skills * Project management skills nice to have Based in Paris Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons " The Real Us*". La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforcons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même

Nature and Scope The Quality Engineer must demonstrate a sound knowledge, application, and proper implementation of technical, quality, and scientific principals necessary to meet industry and customer requirements. The Quality Engineer has the primary responsibility of providing Quality Assurance input to all aspects of Validated systems. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Preparation/review of Quality Assurance, Validation, and Quality Control protocols and reports covering complex systems such as Process Validation, computer-controlled systems validation, complex utilities, complex manufacturing equipment such as filling systems, formulation systems and knowledge of laboratory validation. Works closely with other members of plant quality, manufacturing, calibration services and R&D organizations to accomplish overall objectives; and understand cGMP, and other FDA Guidance Documents, as well as the current processes and practices that are current and ongoing at the American Regent manufacturing/packaging site Identify key quality issues and assist their resolution. Employ knowledge of process improvement techniques and tools such as the DMAIC model, FMEA, process Flow Diagram, Affinity Diagram, Pareto, Control Charts (SCP) Run Charts, SOP etc. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Minimum of 3 years in an FDA regulated environment required, preferably in an Engineering or Validation capacity. Bachelor's degree in Engineering or Science, required. Master's degree preferred. Strong working knowledge of cGMP and Federal (FDA) requirements and guidelines. Strong technical writing skills and knowledge of Good Documentation Practices. Strong knowledge of computer software including Word, Excel, and PowerPoint. Ability to interface with senior level employees from multiple departments. Physical Environment and Requirements While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear. Expected Salary Range: $79,900 - $90,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

SummaryThis position supports product leadership and risk management of new product development and sustaining activities for combination products. The role may include aspects of manufacturability, scalability, manufacturing transfer and post launch sustainability of combination products. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Summary: This position supports product leadership and risk management of new product development and sustaining activities for combination products. The role may include aspects of manufacturability, scalability, manufacturing transfer and post launch sustainability of combination products. This is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future. Job Responsibilities: Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance) and chemical and pharmaceutical operations (e.g., drug product manufacturing, analytical testing, process development and quality assurance) Ability to create, support, review, and investigate analytical test methods used to support pharmaceutical combination devices. The ability to create, support, review chemistry, manufacturing, and controls device submissions Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed Leads development of risk assessments and test method activities (e.g., development and validation for physical and analytical test methods) Leads component qualifications, design validation, design verification, drug stability and process validation Leads product investigations Ability to make and present risked based decisions Assess product changes against product design Supports translation of design inputs into manufacturing control plans Develop and implement procedures to comply with corporate and industry standards. Coordinates and/or directs all aspects of product development activity related to a product line Leads development of risk assessments and test methods Quality engineering representation on Product Development and Design Review teams Prepare and present project updates and technical discussions Participate in project planning, budgeting, scheduling, and tracking Support internal and external supplier audits Provide support to the regulatory department in writing technical submissions Complies with company procedures and policies, government regulations Actively participates in training and providing input to training of employees on division procedures and policies Ability to travel for business, project, and issues approximately up to 25% of time. Other duties and projects, as assigned Education and Experience: BS in Engineering, biological science, or a related engineering field (Masters or Ph.D preferred). Fields of study include Chemical Engineering, Bioengineering, Pharmacy, or Biochemistry Minimum of eight years of experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry Pharmaceutical or combination product experience preferred Required Qualifications: Knows how products are used and impact the user(s) so that risk can be managed effectively Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.) Ability to lead creation of risk management files Ability to develop solutions with business impact Advanced statistical and risk assessment techniques Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies Ability to make and present risk-based decisions Strong interpersonal skills Ability to analyze and optimize manufacturing and quality systems Product, design & prototyping Ability to create and provide training Problem solving ability Ability to create, review and coordinate test protocols and reports Ability to generate engineering proposals Oral and written presentation skills Ability to lead cross functional teams Understanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820 , ICH Guidelines Preferred Qualifications: Quality Engineering Certification (ASQ) or equivalent Physical Demands: While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. Work Environment: While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. Travel required: ≤25% At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA AZ - Tempe HeadquartersAdditional LocationsWork Shift

Job Description A Quality - Visual Inspection Technician is a key member of the Quality Team and plays a critical role in ensuring that compounded pharmaceutical products are accurately prepared and without defects. Visual inspection is the first of several post-production activities where filled compounded products are visually evaluated for product defects. This technician is responsible for working with production and quality staff to prioritize batches for visual inspection, completing visual inspection of batches within reasonable timeframes, appropriately classifying observed defects, and performing additional pre-release inspections. While visual inspection is the main emphasis for this position, this position will also participate in other quality related tasks and duties. Job Activities and Responsibilities: The responsibilities listed below are subject to change. Post-Production Visual Inspection of Finished Drug Products Perform visual inspection of unlabeled finished drug products Classify observed defects into pre-defined categories Calculates percent defects on inspection results and reconciles components Proper documentation of visual inspection activities on associated compounding records in accordance with procedures, CGMP, and CGDP Labeling of Finished Drug Products Label all products following facility and regulatory requirements Perform post-labeling inspections Quality Control Functions and Tasks Perform environmental and personnel monitoring associated with batch production Conduct routine environmental monitoring of controlled compounding areas Record room conditions in appropriate monitoring software Other routine quality control tasks as determined by the Quality Management Quality Assurance and Compliance Adhere to FDA 503B guidelines, cGMP standards, and USP requirements to ensure product safety and quality. Follow established protocols for documentation, reporting, and record-keeping Safety and Facility Maintenance Follow safety protocols, including proper gowning, hand hygiene, and equipment sanitation Participate in routine facility cleaning schedules, ensuring a clean work environment Report any equipment malfunctions or safety concerns to supervisors Assist other process functions as required. Qualifications and Education Requirements Educational Background: High school diploma or equivalent; licensed as a pharmacy technician with the Alabama State Board of Pharmacy. Experience: Prior experience in a pharmacy, healthcare, or manufacturing environment, especially in sterile compounding or quality. Attention to Detail: Effective organization skills, attention to detail, and the maintenance of precise records. Physical Requirements: Ability to stand for extended periods, lift moderate weights, and work in a controlled environment; must have 20/20 vision either aided or unaided and complete inspection certification Must have the ability to complete a two-day off-site training program Physical Requirements: Proficient in using a computer and related equipment, including printers and fax machines. Ability to sit or stand for extended periods. Effective communication skills via telephone and email. Able to work in a controlled environment Capable of lifting up to 40 pounds as needed. 20/20 vision (with or without corrective aids) required for visual inspection of drug products, in accordance with legal requirements. KEY COMPETENCIES Regulatory Knowledge: Familiarity with FDA, cGMP, and USP guidelines is a strong asset. Visual ability to detect defects (as demonstrated through competency assessments) Collaboration: Works well with cross-functional teams, including quality control, shipping, and pharmacists. Regulatory Compliance: Strong understanding of 503B regulations and dedication to following all facility protocols. Benefits: Health care insurance (medical, dental, vision) Life Insurance Supplemental Insurance PTO 401K matching Sick leave

Job Description The Quality Technician ensures that all compounded products are manufactured in accordance with current Good Manufacturing Practices (GMP) and also meet all internal specifications. This position is responsible for performing a number of manual and automated quality assurance checks on in-process products and finished goods. This position requires strong organizational skills and the ability to prioritize work and respond to customer demands in a timely fashion are critical requirements of this position. This position is responsible for working collaboratively with other personnel in the Quality Department to ensure the highest quality product is delivered to the consumer. Job Activities and Responsibilities: Collect and send samples of compounded sterile preparations (CSPs) for sterility, potency, and endotoxin testing. Conduct environmental monitoring (e.g., air and surface sampling) in cleanrooms to ensure compliance with regulatory standards. Perform visual inspection of finished drug products. Maintain incubation schedules of environmental monitoring sample plates and document results in associated reports and batch records. Maintain accurate and thorough records of all testing and inspections. Ensure all documentation complies with FDA 503B regulations, USP standards, and internal SOPs. Review batch records and verify that all procedures were followed correctly. Assist in internal and external audits to ensure compliance with FDA regulations, USP , USP, and other applicable guidelines. Work closely with the Quality Assurance (QA) team to implement corrective and preventive actions (CAPAs) when non-conformities are identified. Maintain effective communication and partnership with Operations Management department. Participate in root cause analysis to find the sources of defects or quality problems. Ensure that all QC laboratory equipment is properly calibrated and maintained according to the manufacturer's specifications. Review of draft and executed batch records, release of pharmaceutical products, and QA review and approval of product label proofs. Participate in continuous improvement initiatives to enhance the quality control processes and overall product quality. Provide input on QC methods and assist in the development of new testing procedures as needed. Assist with SOP training, personnel training and competency assessments for handwashing/garbing and training of quality technicians. Train other staff members on QC procedures and best practices. Stay current with new regulations, guidelines, and techniques related to quality control in 503B compounding Oversight of validation projects (i.e. equipment, facility, methods, and process), deviation investigations, and CAPA and Out of Specifications (OOS) investigations. Ensure all QC activities comply with FDA 503B requirements and other relevant regulatory bodies. Prepare and review QC sections of regulatory submissions. Under the direction of supervisor/lead, document, initiate, and investigate quality events for deviations and noncompliance. Conduct internal audits and gap analysis of processes, systems, and procedures. Assist with external, regulatory inspections. Maintain quality records (equipment calibration and maintenance, training, deviation and noncompliance investigations, environmental monitoring, Certificate of Analysis, clean room certification etc.). Maintain quality standards by approving incoming materials, in-process production, and finished products. Receive, store, and log in samples for testing analysis. Participate in investigations into any deviations, out-of-specification results, or product complaints. Collaborate with QA to resolve issues and prevent recurrence. Other duties, responsibilities and qualifications may be required and/or assigned as necessary. Qualifications and Education Requirements Compounding, cGMP, and/or laboratory experience preferred High school diploma required and Associates or Bachelor's degree in Health Sciences/Microbiology preferred Must be able to follow gowning/garbing procedures including wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles) as outlined in site SOPs Strong written communication and interpersonal skills. Demonstrated ability to work in a demanding, high performance work environment and create a positive, team-oriented culture. Must be well organized and detail-oriented with proven initiative and self-starter skills. Must possess problem solving and analytical skills Demonstrated ability to direct individuals and delegate responsibilities and tasks Excellent work ethic, including a personal drive to excel independently. Solid PC skills including Microsoft Office Suite (Word, Excel, Outlook) 20/20 Vision (either aided or unaided) as required by CGMP regulations for visual inspection of finished drug products. Physical requirements: Ability to use a computer and computer-related equipment, printer/fax machine Prolonged periods of sitting and/or standing. Communicate by telephone and email Lift to forty (40) pounds at times. 20/20 vision (either aided or unaided) Benefits: Health care insurance (medical, dental, vision) Life Insurance Supplemental Insurance PTO 401K matching Sick leave

**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** The In-Process Quality Engineer II- Stability performs essential duties in ensuring the Stability Program operates effectively and in compliance with US and International pharmaceutical manufacturing regulations/guidance documents. The scope of responsibility includes packaging, storage and delivery of stability material in a timely manner to avoid undue burden on the testing laboratories, updating department Work Instructions or site Quality System Procedures and developing solutions to routine technical problems of limited scope to improve department efficiencies. **Job Description** **ESSENTIAL FUNCTIONS** **:** + Responsible for ensuring required stability testing is performed as per procedures, and ensures timely data review for multiple sites + Manages and maintains stability samples under ICH, FDA, DEA and cGMP regulations + Pulls and delivers stability samples at testing intervals + Package stability samples per study requirements for multiple sites + Maintains controlled substance inventory in compliance with applicable DEA regulations + Performs annual physical inventory of controlled substances + Works with LIMS team to ensure stability module of LIMS system is maintained and functional + Manages controlled and non-hazardous destruction inventory + Evaluates analytical data and stability documentation for accuracy and completeness + Provides statistical analysis of stability data + Responsible for packaging, labeling, and storage of stability samples for multiple sites + Creates stability study plans for all stability studies + Create and review stability impact revision protocols + Provide Stability support for sister sites + Train new hires into the department as needed for OJT per the stability training curriculum + Create product stability reports as requested + Receives/approves bulk stability samples in the Biovia and ELN systems. + Support the expansion of the stability program into the Zone IVB market. **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS** **:** + Shares responsibility for Stability Packaging functions and sample pulls as needed. + Reviews and approves stability data sheets + Fulfills regulatory stability requests **MINIMUM REQUIREMENTS** **:** _Education:_ BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies. _Experience:_ Minimum of 1 year related experience in Quality stability programs. Proven project management history. Complete knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements. _Preferred Skills/Qualifications:_ + Excellent communication skills. + Ability to work in and promote a team environment. + Understanding and application of principles, concepts, practices, and standards within discipline. + Knowledge of stability chambers and laboratory equipment. + Ability to read and interpret graphs. + Ability to lead and influence people. + Understanding of basic statistical principles. + Understanding of analytical chemistry and OOS investigations. + Knowledge of US and international pharmaceutical manufacturing regulations/guidance documents _Other Skills:_ Knowledge of ELN, LIMS, Excel, MiniTab. **COMPETENCIES:** Dealing with Ambiguity, Approachability, Decision Quality, Functional/Technical Skills, and Integrity and Trust. Customer Focus **RELATIONSHIPS WITH OTHERS:** Works frequently with internal customers including QC, Manufacturing, Logistics, Regulatory, QA, Validation, APIDs, Maintenance/Engineering, and EHS. Also serves as a representative during audits with customers, regulatory, and internal entities. **WORKING CONDITIONS:** + 50% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds. + 50% Office environment which includes sitting for long periods of time and computer use. **DISCLAIMER:** _The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position._ **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The In-Process Quality Engineer II- Stability performs essential duties in ensuring the Stability Program operates effectively and in compliance with US and International pharmaceutical manufacturing regulations/guidance documents. The scope of responsibility includes packaging, storage and delivery of stability material in a timely manner to avoid undue burden on the testing laboratories, updating department Work Instructions or site Quality System Procedures and developing solutions to routine technical problems of limited scope to improve department efficiencies. Job Description ESSENTIAL FUNCTIONS: Responsible for ensuring required stability testing is performed as per procedures, and ensures timely data review for multiple sites Manages and maintains stability samples under ICH, FDA, DEA and cGMP regulations Pulls and delivers stability samples at testing intervals Package stability samples per study requirements for multiple sites Maintains controlled substance inventory in compliance with applicable DEA regulations Performs annual physical inventory of controlled substances Works with LIMS team to ensure stability module of LIMS system is maintained and functional Manages controlled and non-hazardous destruction inventory Evaluates analytical data and stability documentation for accuracy and completeness Provides statistical analysis of stability data Responsible for packaging, labeling, and storage of stability samples for multiple sites Creates stability study plans for all stability studies Create and review stability impact revision protocols Provide Stability support for sister sites Train new hires into the department as needed for OJT per the stability training curriculum Create product stability reports as requested Receives/approves bulk stability samples in the Biovia and ELN systems. Support the expansion of the stability program into the Zone IVB market. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Shares responsibility for Stability Packaging functions and sample pulls as needed. Reviews and approves stability data sheets Fulfills regulatory stability requests MINIMUM REQUIREMENTS: Education: BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies. Experience: Minimum of 1 year related experience in Quality stability programs. Proven project management history. Complete knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements. Preferred Skills/Qualifications: Excellent communication skills. Ability to work in and promote a team environment. Understanding and application of principles, concepts, practices, and standards within discipline. Knowledge of stability chambers and laboratory equipment. Ability to read and interpret graphs. Ability to lead and influence people. Understanding of basic statistical principles. Understanding of analytical chemistry and OOS investigations. Knowledge of US and international pharmaceutical manufacturing regulations/guidance documents Other Skills: Knowledge of ELN, LIMS, Excel, MiniTab. COMPETENCIES: Dealing with Ambiguity, Approachability, Decision Quality, Functional/Technical Skills, and Integrity and Trust. Customer Focus RELATIONSHIPS WITH OTHERS: Works frequently with internal customers including QC, Manufacturing, Logistics, Regulatory, QA, Validation, APIDs, Maintenance/Engineering, and EHS. Also serves as a representative during audits with customers, regulatory, and internal entities. WORKING CONDITIONS: 50% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds. 50% Office environment which includes sitting for long periods of time and computer use. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary Depending on the laboratory area, will perform analysis on Raw Materials, Intermediates, In-Process, Finished Product, or Stability samples using established analytical methods. Job Description ESSENTIAL FUNCTIONS: Follow good documentation practices for the accurate and timely documentation of all activities. Perform wet chemistry and instrumentation testing. Follow site HSE Policies. Assist with establishing and maintaining safe work standards in the lab. Peer review all levels of work. Conducts lab investigations. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: LIMS entry of data Use of analytical balances, HPLC, GC, KF Titrator, UV, pH Meter Maintain instrument readiness MINIMUM REQUIREMENTS: Education: High School Diploma required, associate degree in a science related field or equivalent combined education, experience, and competencies preferred. Experience: Experience in a cGMP environment is preferred. Working knowledge of instrumentation preferred. Preferred Skills/Qualifications: Working knowledge of wet chemistry required Working knowledge of instrumentation (GC/LC, UV, AA). Experience in a cGMP environment is preferred. Basic computer skills and familiarity with Microsoft Office Suite. Substantial acquaintance with and understanding of application of basic principles, theories and concept. Use and/or Basic knowledge of industry practices and standards. Chromatography (GC/LC) and Spectroscopy experience a plus. COMPETENCIES: Informing, Customer Focus, Listening, Perseverance, Organizing, function/technical skills, Peer Relationships, Comfort around Higher Management ORGANIZATIONAL RELATIONSHIP/SCOPE: Contacts involve matters of moderate importance to the organization and include R&D, Marketing, Production employees including Engineers, Supervisors, and Operators, Logistics, EHS, and DEA. Infrequent customer contacts on routine matters. WORKING CONDITIONS: 80% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds. 20% Office environment. Weekend Day Shift: 12 hours per day, 6:00 a.m. - 6:30 p.m. Saturday, Sunday, Monday, and every other Tuesday. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills require EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview As a Process Engineer I, you'll launch your career in chemical engineering with the support of highly experienced engineers and scientists who are eager to mentor and guide you. In this role, you'll be immersed in every stage of bringing new products from the laboratory to full-scale manufacturing, gaining hands-on experience with batch processes and unit operations such as reactions, distillation, extraction, filtration, and drying. Because we are a global contract development and manufacturing organization, you'll have the unique opportunity to work on several different chemical processes each year and collaborate directly with pharmaceutical clients from around the world. This role is designed to accelerate your professional growth, giving you the chance to learn, contribute, and make a real impact early in your career. Reporting to a Senior Manager, Process Engineering, the Process Engineer I is part of a team responsible for the cGMP manufacture of active pharmaceutical ingredients. The engineer will apply their knowledge of chemical engineering fundamentals to assist project teams translating new chemical processes to manufacturing. Projects include small-scale development, technology transfer, pilot-scale production, validation, and support of commercial manufacturing. Responsibilities Under the guidance of senior engineers and scientists: Perform scaling calculations for unit operations, assisting with the conceptual process design. Participate in process reviews for operability, safety, and quality. Play a support role, providing information to external clients and internal stakeholders. Support production campaigns through in-person observation. Analyze production and laboratory data to assist with process understanding. Assist with quality investigations and corrective action / preventative action implementation. Support process improvement projects to reduce cycle time, increase yield, and improve quality. Draft manufacturing documents: process flow diagrams, batch records, validation protocols, standard operating procedures, quality investigations, campaign reports. Qualifications/Skills Applied Math and Science: A strong understanding of the core chemical engineering fundamentals (thermodynamics, heat transfer, mass transfer, transport, kinetics, etc. ). Data Analysis, Visualization, Troubleshooting: The ability to analyze data from various sources, including sensors and experiments, to identify trends, troubleshoot issues, and improve efficiency. Process Simulation and Modeling: With training and support from senior engineers, use software (spreadsheets, programming, simulators) to model chemical unit operations and processes. Process Safety and Risk Management: With training and support from senior engineers, assess and manage risks associated with chemical processes, ensuring the safety of personnel and the environment. Process Scale Up & Equipment knowledge: With training and support from senior engineers, assess equipment capability of key processing equipment (reactors, filters, heat exchangers) with respect to process fit. Problem-Solving: With training and support from senior engineers, identify, analyze, and solve complex problems related to chemical processes and plant operations. Includes investigations. Technical Writing & Communication: The ability to explain technical concepts clearly and accurately to technical and non-technical audiences. Attention to Detail: Be meticulous and pay close attention to detail to ensure accuracy and quality. Adaptability: The ability to adapt to changing priorities, new technologies, and unexpected challenges is important. Time Management: Ability to handle key assignments, meeting deadlines with supervision. Education, Experience & Licensing Requirements B. S. degree in Chemical Engineering or related field. Experience in a chemical manufacturing environment, particularly pharmaceutical, is preferred. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. #LI-RD1B. S. degree in Chemical Engineering or related field. Experience in a chemical manufacturing environment, particularly pharmaceutical, is preferred. Under the guidance of senior engineers and scientists: Perform scaling calculations for unit operations, assisting with the conceptual process design. Participate in process reviews for operability, safety, and quality. Play a support role, providing information to external clients and internal stakeholders. Support production campaigns through in-person observation. Analyze production and laboratory data to assist with process understanding. Assist with quality investigations and corrective action / preventative action implementation. Support process improvement projects to reduce cycle time, increase yield, and improve quality. Draft manufacturing documents: process flow diagrams, batch records, validation protocols, standard operating procedures, quality investigations, campaign reports.